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CompletedNCT05218434Updated Aug 23, 2024Results posted

A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses

A Phase 1 interventional study of AX-158 in Autoimmune Diseases, sponsored by Artax Biopharma Inc. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Artax Biopharma Inc · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

This is a Phase I Healthy volunteer study with the primary objective to evaluate the safety and pharmacokinetics profile of AX-158. The first part will evaluate single ascending dose administrations. A substudy will be performed as well to evaluate possible impact of food on drug exposure if administered under fasted or fed state. The second part will evaluate multiple ascending dose over 10 days of dosing in fed or fast state depending on the results of the substudy food effect on AX-158.

Read the detailed description

This is a phase I, randomised, double-blind , placebo controlled study to investigate the safety, tolerability, and PK of AX-158 in healthy male participants following single (Part A) and multiple (Part C) ascending doses including food effect (Part B).The study will be conducted in three parts (Part A, Part B and Part C). Part A will enrol 8 participants per cohort randomised (3 :1) to receive AX-158 (6 participants) or placebo (2 participants). Part A will follow a single ascending dose (SAD) design with all participants receiving one dose of AX-158 (or placebo) in the fasted state. Part B (Food Effect) will be conducted in 8 participants in a cross-over manner; each participant will receive AX-158 in the fed and fasted state. Part C will enrol 8 participants per cohort randomised to (3 :1) to receive AX-158 (6 participants) or placebo (2 participants). Part C will follow a multiple ascending dose (MAD) design with participants receiving AX-158 (or placebo) once daily for 10 consecutive days, in a fed or fasted state (depending on the outcome of the Part B (Food Effect).

02

Conditions studied

  • Autoimmune Diseases

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03

In context

Autoimmune Diseases

655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.

This study's enrollment of 64 is above the median of 40 across 427 interventional studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

Artax Biopharma Inc is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy Male participant, between 18 and 50 years of age, inclusive.
  2. Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception in addition to a condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 4 months after last dose of Investigational Medicinal Product (IMP).
  3. Participant with a body mass index (BMI) of 18-30kg/m2. BMI = body weight (kg) / [height (m)]2.
  4. Total serum bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). If total bilirubin is above the upper limit of normal and is then fractionated, direct bilirubin must be within normal limits.
  5. Total serum Testosterone levels 2 x above the lower limit of the normal range within 28 days before the first dose administration of the IMP.
  6. Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator's discretion).
  7. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening.
  8. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IMP including a QRS interval > 120ms, PR interval > 220ms and QTcF > 450ms.
  9. No clinically significant abnormalities in vital signs (e.g., blood pressure/pulse rate, respiration rate and oral temperature) determined within 28 days before first dose of IMP.
  10. Participant must be available to complete the study (including all follow-up visits).
  11. Participant must satisfy an Investigator about his fitness to participate in the study.
  12. Participant must provide written informed consent to participate in the study.
  13. Participants with a negative COVID-19 PCR test on admission.

Exclusion criteria

Exclusion Criteria:

  1. A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
  2. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP. Occasional use of paracetamol will be allowed.
  3. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction.
  4. Clinically significant history of previous allergy / sensitivity to AX-158 or any of the excipients contained within the IMP.
  5. Participant with history of autoimmune disease, cardiac disease, kidney disease or any food intolerance.
  6. Participants with clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP
  7. A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units [for male and female participants] of alcohol a week) within the past two years.
  8. Inability to communicate well with the Investigators (i.e., language problem, poor mental development, or impaired cerebral function).
  9. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
  10. Donation of 450 milliliters or more blood within the 3 months before the first dose of IMP.
  11. Vegans, vegetarians, or other dietary restrictions (e.g., restrictions for medical, religious, or cultural reasons, etc), which would prevent participants from consuming a high-fat breakfast or standardised meal.
  12. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).
  13. Participants who have received a COVID-19 vaccine injection within 28 days prior to the first dose of IMP.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Part A - 5mg AX-158

    AX-158 oral Single (Single Ascending Dose)

    Drug: AX-158

  • Experimental
    Part A - 10mg AX-158

    AX-158 oral Single (Single Ascending Dose)

    Drug: AX-158

  • Experimental
    Part A - 15mg AX-158 or Placebo

    AX-158 oral Single (Single Ascending Dose)

    Drug: AX-158

  • Experimental
    Part A - 25mg AX-158

    AX-158 oral Single (Single Ascending Dose)

    Drug: AX-158

  • Experimental
    Part A -50mg AX-158

    AX-158 oral Single (Single Ascending Dose)

    Drug: AX-158

  • Experimental
    Part B - 15mg AX-158 Fed state

    AX-158 oral single dose with food

    Drug: AX-158

  • Experimental
    Part B - 15mg AX-158 Fasted

    AX-158 oral single dose without food

    Drug: AX-158

  • Experimental
    Part C - 5mg AX-158

    AX-158 oral daily dose for 10 days (Multiple Ascending Dose)

    Drug: AX-158

  • Experimental
    Part C - 10mg AX-158

    AX-158 oral daily dose for 10 days (Multiple Ascending Dose)

    Drug: AX-158

  • Experimental
    Part C - 15mg AX-158

    AX-158 oral daily dose for 10 days (Multiple Ascending Dose)

    Drug: AX-158

  • Experimental
    Part A - Placebo

    Placebo oral Single (Single Ascending Dose)

    Drug: AX-158

  • Experimental
    Part C - Placebo

    Placebo oral daily dose for 10 days (Multiple Ascending Dose)

    Drug: AX-158

Interventions

  • DrugAX-158

    Oral administrations of AX-158

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

    The number of participants with recorded treatment emergent adverse events following single and multiple doses of AX-158.

    Time frame: Up to 10 days of treatment

Secondary outcomes

  1. Maximal Plasma Concentration (Cmax)

    Values calculated for derived PK parameters following samples obtained at the following timepoints: Part A \& B: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, Day 2: 24 hr, 36 hr, Day 3: 48 hr \& Day 4: 72 hr post-Day 1 dose Part C: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 1 dose Day 2: 24 hr, 36 hr post-Day 1 dose Day 3: 48 hr post-Day 1 dose Day 4: 72 hr post-Day 1 dose Day 5: prior to dose Day 10: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 10 dose Day 11: 24 hr, 36 hr post-Day 10 dose Day 12: 48 hr post-Day 10 dose Day 13: 72 hr post-Day 10 dose

    Time frame: Up to 13 days following dose administration

  2. Total Plasma Drug Exposure (AUC0-t)

    Values calculated for derived PK parameters following samples obtained at the following timepoints: Part A \& B: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, Day 2: 24 hr, 36 hr, Day 3: 48 hr \& Day 4: 72 hr post-Day 1 dose Part C: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 1 dose Day 2: 24 hr, 36 hr post-Day 1 dose Day 3: 48 hr post-Day 1 dose Day 4: 72 hr post-Day 1 dose Day 5: prior to dose Day 10: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 10 dose Day 11: 24 hr, 36 hr post-Day 10 dose Day 12: 48 hr post-Day 10 dose Day 13: 72 hr post-Day 10 dose

    Time frame: Up to 13 days following dose administration

  3. Terminal Half Life (t1/2)

    Values calculated for derived PK parameters following samples obtained at the following timepoints: Part A \& B: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, Day 2: 24 hr, 36 hr, Day 3: 48 hr \& Day 4: 72 hr post-Day 1 dose Part C: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 1 dose Day 2: 24 hr, 36 hr post-Day 1 dose Day 3: 48 hr post-Day 1 dose Day 4: 72 hr post-Day 1 dose Day 5: prior to dose Day 10: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 10 dose Day 11: 24 hr, 36 hr post-Day 10 dose Day 12: 48 hr post-Day 10 dose Day 13: 72 hr post-Day 10 dose

    Time frame: Up to 13 days following dose administration

07

Results

Posted Aug 23, 2024

Participant flow

Study recruitment for this study was undertaken in South Wales in the United Kingdom. A sufficient number of participants were screened in order to successfully recruit 64 eligible participants.

Participant flow — Overall Study
MilestonePart A - 5 mg AX-158Part A - 10 mg AX-158Part A - 15 mg AX-158Part A - 25 mg AX-158Part A - 50 mg AX-158Part A - Placebo ParticipantsPart B - 15 mg AX-158 Fed/FastedPart C - 5 mg AX-158Part C - 10 mg AX-158Part C - 15 mg AX-158Part C - Placebo
Started65446986565
Completed65446986565
Not completed00000000000

Outcome measures

PrimaryNumber of Participants With Treatment-Emergent Adverse Events

The number of participants with recorded treatment emergent adverse events following single and multiple doses of AX-158.

Time frame:
Up to 10 days of treatment
Reported as:
Number · participants
Number of Participants With Treatment-Emergent Adverse Events
participantsPart A - 5 mg AX-158Part A - 10 mg AX-158Part A - 15 mg AX-158Part A - 25 mg AX-158Part A - 50 mg AX-158Part B - 15 mg AX-158 Fed StatePart B - 15 mg AX-158 FastedPart C - 5 mg AX-158Part C - 10 mg AX-158Part C - 15 mg AX-158Part A - PlaceboPart C - Placebo
Number of Participants With Treatment-Emergent Adverse Events000001131014
SecondaryMaximal Plasma Concentration (Cmax)

Values calculated for derived PK parameters following samples obtained at the following timepoints: Part A \& B: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, Day 2: 24 hr, 36 hr, Day 3: 48 hr \& Day 4: 72 hr post-Day 1 dose Part C: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 1 dose Day 2: 24 hr, 36 hr post-Day 1 dose Day 3: 48 hr post-Day 1 dose Day 4: 72 hr post-Day 1 dose Day 5: prior to dose Day 10: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 10 dose Day 11: 24 hr, 36 hr post-Day 10 dose Day 12: 48 hr post-Day 10 dose Day 13: 72 hr post-Day 10 dose

Time frame:
Up to 13 days following dose administration
Reported as:
Geometric mean · µg/mL
Maximal Plasma Concentration (Cmax)
µg/mLPart A - 5 mg AX-158Part A - 10 mg AX-158Part A - 15 mg AX-158Part A - 25 mg AX-158Part A - 50 mg AX-158Part B - 15 mg AX-158 FedPart B - 15 mg AX-158 FastedPart C - 5 mg AX-158Part C - 10 mg AX-158Part C - 15 mg AX-158
Maximal Plasma Concentration (Cmax)0.0831 ± 16.30.174 ± 9.70.29 ± 100.487 ± 15.80.86 ± 18.90.237 ± 20.70.273 ± 26.30.108 ± 7.10.194 ± 15.40.298 ± 17.5
SecondaryTotal Plasma Drug Exposure (AUC0-t)

Values calculated for derived PK parameters following samples obtained at the following timepoints: Part A \& B: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, Day 2: 24 hr, 36 hr, Day 3: 48 hr \& Day 4: 72 hr post-Day 1 dose Part C: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 1 dose Day 2: 24 hr, 36 hr post-Day 1 dose Day 3: 48 hr post-Day 1 dose Day 4: 72 hr post-Day 1 dose Day 5: prior to dose Day 10: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 10 dose Day 11: 24 hr, 36 hr post-Day 10 dose Day 12: 48 hr post-Day 10 dose Day 13: 72 hr post-Day 10 dose

Time frame:
Up to 13 days following dose administration
Reported as:
Geometric mean · h*µg/mL
Total Plasma Drug Exposure (AUC0-t)
h*µg/mLPart A - 5 mg AX-158Part A - 10 mg AX-158Part A - 15 mg AX-158Part A - 25 mg AX-158Part A - 50 mg AX-158Part B - 15 mg AX-158 FedPart B - 15 mg AX-158 FastedPart C - 5 mg AX-158Part C - 10 mg AX-158Part C - 15 mg AX-158
Total Plasma Drug Exposure (AUC0-t)1.07 ± 35.62.06 ± 20.83.87 ± 25.26.88 ± 3411.9 ± 24.63.3 ± 36.33.43 ± 341.67 ± 22.52.65 ± 38.64.97 ± 28.5
SecondaryTerminal Half Life (t1/2)

Values calculated for derived PK parameters following samples obtained at the following timepoints: Part A \& B: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, Day 2: 24 hr, 36 hr, Day 3: 48 hr \& Day 4: 72 hr post-Day 1 dose Part C: Day 1: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 1 dose Day 2: 24 hr, 36 hr post-Day 1 dose Day 3: 48 hr post-Day 1 dose Day 4: 72 hr post-Day 1 dose Day 5: prior to dose Day 10: pre-dose, 30 mins, 45 mins, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr post-Day 10 dose Day 11: 24 hr, 36 hr post-Day 10 dose Day 12: 48 hr post-Day 10 dose Day 13: 72 hr post-Day 10 dose

Time frame:
Up to 13 days following dose administration
Reported as:
Geometric mean · h
Terminal Half Life (t1/2)
hPart A - 5 mg AX-158Part A - 10 mg AX-158Part A - 15 mg AX-158Part A - 25 mg AX-158Part A - 50 mg AX-158Part B - 15 mg AX-158 FedPart B - 15 mg AX-158 FastedPart C - 5 mg AX-158Part C - 10 mg AX-158Part C - 15 mg AX-158
Terminal Half Life (t1/2)8.94 ± 18.48.48 ± 13.18.56 ± 22.110.6 ± 25.49.58 ± 10.58.19 ± 25.68.44 ± 18.89.7 ± 4.78.41 ± 21.49.84 ± 20.9

Adverse events

Collected over Adverse Event reporting and data collection occurred over the following time frames for each study part: Part A - informed consent to follow up - up to 6 weeks Part B - informed consent to follow up - up to 8 weeks Part C - informed consent to follow up - up to 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A - 5 mg AX-1580/6 (0%)—0/6 (0%)
Part A - 10 mg AX-1580/5 (0%)0/5 (0%)0/5 (0%)
Part A - 15 mg AX-1580/4 (0%)0/4 (0%)0/4 (0%)
Part A - 25 mg AX-1580/4 (0%)0/4 (0%)0/4 (0%)
Part A - 50 mg AX-1580/6 (0%)0/6 (0%)1/6 (16.7%)
Part A - Placebo0/9 (0%)0/9 (0%)1/9 (11.1%)
Part B - 15 mg AX-158 Fed0/8 (0%)0/8 (0%)1/8 (12.5%)
Part B - 15 mg AX-158 Fasted0/8 (0%)0/8 (0%)1/8 (12.5%)
Part C - 5 mg AX-1580/6 (0%)0/6 (0%)1/6 (16.7%)
Part C - 10 mg AX-1580/5 (0%)0/5 (0%)1/5 (20%)
Part C - 15 mg AX-1580/6 (0%)0/6 (0%)0/6 (0%)
Part C - Placebo0/5 (0%)0/5 (0%)2/5 (40%)
Most frequent other events
Most frequent other events
EventPart A - 5 mg AX-158Part A - 10 mg AX-158Part A - 15 mg AX-158Part A - 25 mg AX-158Part A - 50 mg AX-158Part A - PlaceboPart B - 15 mg AX-158 FedPart B - 15 mg AX-158 FastedPart C - 5 mg AX-158Part C - 10 mg AX-158Part C - 15 mg AX-158Part C - Placebo
EpistaxisRespiratory, thoracic and mediastinal disorders0/60/50/40/40/61/90/80/80/60/50/61/5
HeadacheNervous system disorders0/60/50/40/41/60/91/80/81/61/50/60/5
Nasal CongestionRespiratory, thoracic and mediastinal disorders0/60/50/40/40/60/90/80/80/60/50/61/5
CoughRespiratory, thoracic and mediastinal disorders0/60/50/40/40/60/90/80/80/60/50/61/5
AnxietyPsychiatric disorders0/60/50/40/40/60/90/80/81/60/50/60/5
Abdominal DistensionGastrointestinal disorders0/60/50/40/40/60/90/80/81/60/50/60/5
Seasonal AllergyImmune system disorders0/60/50/40/40/60/90/81/80/60/50/60/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Part A - 5mg AX-158Part A - 10mg AX-158Part A - 15mg AX-158Part A - 25mg AX-158Part A - 50mg AX-158Part A - PlaceboPart B - 15mg AX-158 Fed/FastedPart C - 5mg AX-158Part C - 10mg AX-158Part C - 15mg AX-158Part C - PlaceboTotal
<=18 years000000000000
Between 18 and 65 years6544698656564
>=65 years000000000000
Sex: Female, Male
Sex: Female, Male(Participants)Part A - 5mg AX-158Part A - 10mg AX-158Part A - 15mg AX-158Part A - 25mg AX-158Part A - 50mg AX-158Part A - PlaceboPart B - 15mg AX-158 Fed/FastedPart C - 5mg AX-158Part C - 10mg AX-158Part C - 15mg AX-158Part C - PlaceboTotal
Female000000000000
Male6544698656564
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part A - 5mg AX-158Part A - 10mg AX-158Part A - 15mg AX-158Part A - 25mg AX-158Part A - 50mg AX-158Part A - PlaceboPart B - 15mg AX-158 Fed/FastedPart C - 5mg AX-158Part C - 10mg AX-158Part C - 15mg AX-158Part C - PlaceboTotal
Hispanic or Latino000000000011
Not Hispanic or Latino6544698656463
Unknown or Not Reported000000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Part A - 5mg AX-158Part A - 10mg AX-158Part A - 15mg AX-158Part A - 25mg AX-158Part A - 50mg AX-158Part A - PlaceboPart B - 15mg AX-158 Fed/FastedPart C - 5mg AX-158Part C - 10mg AX-158Part C - 15mg AX-158Part C - PlaceboTotal
American Indian or Alaska Native000000000000
Asian000000000000
Native Hawaiian or Other Pacific Islander000000000000
Black or African American000000000000
White5544698646562
More than one race100000001002
Unknown or Not Reported000000000000
Height
Height(Metres)Part A - 5mg AX-158Part A - 10mg AX-158Part A - 15mg AX-158Part A - 25mg AX-158Part A - 50mg AX-158Part A - PlaceboPart B - 15mg AX-158 Fed/FastedPart C - 5mg AX-158Part C - 10mg AX-158Part C - 15mg AX-158Part C - PlaceboTotal
Mean1.800 ± 0.06201.788 ± 0.03701.780 ± 0.05941.783 ± 0.06991.762 ± 0.04361.783 ± 0.05321.771 ± 0.06171.747 ± 0.05921.772 ± 0.06941.805 ± 0.04851.734 ± 0.04881.783 ± 0.0513
Weight
Weight(Kg)Part A - 5mg AX-158Part A - 10mg AX-158Part A - 15mg AX-158Part A - 25mg AX-158Part A - 50mg AX-158Part A - PlaceboPart B - 15mg AX-158 Fed/FastedPart C - 5mg AX-158Part C - 10mg AX-158Part C - 15mg AX-158Part C - PlaceboTotal
Mean83.2 ± 12.01982.62 ± 5.03474.60 ± 8.63681.53 ± 12.82975.55 ± 6.48681.24 ± 10.98984.34 ± 11.24473.25 ± 9.19476.74 ± 11.95979.88 ± 12.01567.78 ± 2.84280.01 ± 9.638
BMI
BMI(kg/m2)Part A - 5mg AX-158Part A - 10mg AX-158Part A - 15mg AX-158Part A - 25mg AX-158Part A - 50mg AX-158Part A - PlaceboPart B - 15mg AX-158 Fed/FastedPart C - 5mg AX-158Part C - 10mg AX-158Part C - 15mg AX-158Part C - PlaceboTotal
Mean25.508 ± 2.178325.880 ± 2.009223.580 ± 2.895625.548 ± 2.574524.313 ± 1.369025.557 ± 3.351926.850 ± 3.054424.053 ± 3.224724.392 ± 3.030224.672 ± 4.581722.584 ± 1.525725.143 ± 2.4850
08

Study locations

1 site
  • Simbec-Orion
    Merthyr Tydfil, United Kingdom
09

References and documents

Publications

  • Borroto A, Reyes-Garau D, Jimenez MA, Carrasco E, Moreno B, Martinez-Pasamar S, Cortes JR, Perona A, Abia D, Blanco S, Fuentes M, Arellano I, Lobo J, Heidarieh H, Rueda J, Esteve P, Cibrian D, Martinez-Riano A, Mendoza P, Prieto C, Calleja E, Oeste CL, Orfao A, Fresno M, Sanchez-Madrid F, Alcami A, Bovolenta P, Martin P, Villoslada P, Morreale A, Messeguer A, Alarcon B. First-in-class inhibitor of the T cell receptor for the treatment of autoimmune diseases. Sci Transl Med. 2016 Dec 21;8(370):370ra184. doi: 10.1126/scitranslmed.aaf2140. PubMed 28003549 ↗
  • Roy E, Togbe D, Holdorf AD, Trubetskoy D, Nabti S, Kublbeck G, Klevenz A, Kopp-Schneider A, Leithauser F, Moller P, Bladt F, Hammerling G, Arnold B, Pawson T, Tafuri A. Nck adaptors are positive regulators of the size and sensitivity of the T-cell repertoire. Proc Natl Acad Sci U S A. 2010 Aug 31;107(35):15529-34. doi: 10.1073/pnas.1009743107. Epub 2010 Aug 13. PubMed 20709959 ↗
  • Roy E, Togbe D, Holdorf A, Trubetskoy D, Nabti S, Kublbeck G, Schmitt S, Kopp-Schneider A, Leithauser F, Moller P, Bladt F, Hammerling GJ, Arnold B, Pawson T, Tafuri A. Fine tuning of the threshold of T cell selection by the Nck adapters. J Immunol. 2010 Dec 15;185(12):7518-26. doi: 10.4049/jimmunol.1000008. Epub 2010 Nov 15. PubMed 21078909 ↗
  • Gil D, Schamel WW, Montoya M, Sanchez-Madrid F, Alarcon B. Recruitment of Nck by CD3 epsilon reveals a ligand-induced conformational change essential for T cell receptor signaling and synapse formation. Cell. 2002 Jun 28;109(7):901-12. doi: 10.1016/s0092-8674(02)00799-7. PubMed 12110186 ↗
  • Juraske C, Wipa P, Morath A, Hidalgo JV, Hartl FA, Raute K, Oberg HH, Wesch D, Fisch P, Minguet S, Pongcharoen S, Schamel WW. Anti-CD3 Fab Fragments Enhance Tumor Killing by Human gammadelta T Cells Independent of Nck Recruitment to the gammadelta T Cell Antigen Receptor. Front Immunol. 2018 Jul 9;9:1579. doi: 10.3389/fimmu.2018.01579. eCollection 2018. PubMed 30038626 ↗
  • Borroto A, Arellano I, Blanco R, Fuentes M, Orfao A, Dopfer EP, Prouza M, Suchanek M, Schamel WW, Alarcon B. Relevance of Nck-CD3 epsilon interaction for T cell activation in vivo. J Immunol. 2014 Mar 1;192(5):2042-53. doi: 10.4049/jimmunol.1203414. Epub 2014 Jan 27. PubMed 24470497 ↗
  • Borroto A, Arellano I, Dopfer EP, Prouza M, Suchanek M, Fuentes M, Orfao A, Schamel WW, Alarcon B. Nck recruitment to the TCR required for ZAP70 activation during thymic development. J Immunol. 2013 Feb 1;190(3):1103-12. doi: 10.4049/jimmunol.1202055. Epub 2012 Dec 24. PubMed 23267019 ↗
  • Lettau M, Pieper J, Gerneth A, Lengl-Janssen B, Voss M, Linkermann A, Schmidt H, Gelhaus C, Leippe M, Kabelitz D, Janssen O. The adapter protein Nck: role of individual SH3 and SH2 binding modules for protein interactions in T lymphocytes. Protein Sci. 2010 Apr;19(4):658-69. doi: 10.1002/pro.334. PubMed 20082308 ↗
  • Yiemwattana I, Ngoenkam J, Paensuwan P, Kriangkrai R, Chuenjitkuntaworn B, Pongcharoen S. Essential role of the adaptor protein Nck1 in Jurkat T cell activation and function. Clin Exp Immunol. 2012 Jan;167(1):99-107. doi: 10.1111/j.1365-2249.2011.04494.x. PubMed 22132889 ↗

Study documents

  • Study protocol · Jan 14, 2022
  • Statistical analysis plan · Dec 14, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05218434
Lead sponsor
Artax Biopharma Inc
Collaborators
Simbec-Orion Group
Responsible party
Sponsor
First posted
Feb 1, 2022
Start date
Nov 17, 2021
Primary completion
Nov 16, 2022
Completion
Dec 3, 2022
Results posted
Aug 23, 2024
Last update
Aug 23, 2024

Study contacts

Dr Annelize Koch
principal investigator · Simbec-Orion Merthyr Tydfil CF48 4DR, United Kingdom

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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