ClinicalTrials.gg
Sign In
CompletedNCT01166984Updated Jun 9, 2021Results posted

AB103 Peptide Antagonist in Healthy Volunteers

A Phase 1 interventional study of AB103 and Placebo in Healthy Volunteer Safety Study, sponsored by Atox Bio Ltd. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-09.

Sponsored by Atox Bio Ltd · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The primary objective of this study is to establish the safety profile and maximum tolerated dose (MTD) of AB103 given as a single intravenous (IV) infusion in healthy volunteers.

Read the detailed description

After consent and establishing eligibility for the study, each subject received a single IV infusion of escalating doses of AB103 (7.5, 37.5, 150, 450 μg/kg in 5 subjects at each dose) or placebo (n=5). Screening blood chemistry, hematology, coagulation, urinalysis, vital signs, and electrocardiogram (ECG) were used to assure medical fitness to participate in the study. These measures were repeated during and after treatment with AB103 to monitor for adverse events (AEs). ECG and pulse oximetry was monitored continuously starting 15 minutes before the infusion and for 2 hours after each infusion. Vital signs (sitting blood pressure, temperature, heart rate, respiratory rate, and pulse oximetry) and ECG measurements were recorded every 15 minutes for the first two hours starting from the beginning of the infusion and then approximately 24 hours later. Blood chemistry, hematology, coagulation, and urinalysis, were repeated one day and one week after infusions. AEs either observed by the investigator or reported spontaneously by the subjects were recorded at each study visit. Subjects kept a 7-day diary starting on the day of infusion to record any AEs. The primary basis on which escalation was based was dose limiting toxicities (DLTs) defined as the emergence of one or more selected AEs that reached a threshold which justified stopping the trial. After safety monitoring committee review of safety data, progression to the next cohort was to occur as follows:

  1. If none of the 5 AB103 subjects in a cohort experienced a non-extreme DLT, escalation to the next dose cohort was to occur.
  2. If 1 of 5 subjects receiving AB103 in a cohort experienced a non-extreme DLT, then a total of 8 subjects (6 active: 2 placebo) were to be enrolled in that cohort before escalating to the next dose (escalation will only occur if no additional subjects (2 total) have a non-extreme DLT).
  3. If there were 0/6 or 1/6 active subjects with a non-extreme DLT at the highest dose, the highest dose was to be considered the MTD. If there were 2/6 active subjects with a non-extreme DLT in a cohort, then the next lowest dose was to be considered the MTD.
  4. If an extreme DLT occurred, the study was to be halted immediately.

Subjects in Cohorts #1 to #3 had a blood sample (40 milliliters, mL) drawn pre-infusion, 24 hours after the infusion (Day 2), and a final sample at the Day 6-8 clinic visit (total of 120 mL) for leukocyte phenotyping by flow cytometry. Subjects in Cohort #4 had a blood sample (40 mL) drawn pre-infusion, 1 hour after the infusion, and a final sample at the Day 6-8 clinic visit (total of 120 mL) for leukocyte phenotyping by flow cytometry.

For the pharmacokinetic (PK) analysis, blood was collected at the mid-point of the infusion and 1, 2, 5, 10, 20, 30, and 60 minutes and approximately 24 hours post-infusion, and plasma was isolated for quantitation of AB103 peptide concentrations.

02

Conditions studied

  • Healthy Volunteer Safety Study

Keywords

  • sepsis
  • septic shock
03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's enrollment of 25 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Atox Bio Ltd 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 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be able to read, understand and sign the form and be willing to participate in all study procedures for the duration of the study.
  • Be 18-to-40 years-of-age.
  • Have adequate venous access.
  • Have a between 20 and 29 kg/m2.
  • Have a history and physical examination that demonstrate no for participating in the study, in the judgment of the admitting physician and/or the site investigator.
  • Have vital signs as follows: resting heart rate between 50 and 90 beats per minute (bpm), systolic blood pressure (BP) below 150 mm Hg and diastolic BP below 90 mm Hg.
  • Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels within 10% of normal laboratory limits.
  • If female, not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, have a negative pregnancy test.
  • Agree to exercise adequate from the time of the screening procedures to 14 days after the agent administration (both males and females).
  • Have an (ECG) performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant arrhythmias.

Exclusion criteria

Exclusion Criteria:

  • Be pregnant or lactating.
  • Have disease or asthma.
  • Have been febrile within 3-days of the first infusion.
  • Have a history of migraine headaches, as diagnosed by a physician.
  • Have any acute or chronic medical illnesses or other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
  • Be taking any medications to treat a chronic medical condition.
  • Have participated in a research study where they received any experimental products within 30 days prior to study entry.
  • Have ongoing drug abuse/dependence (including alcohol) by medical history.
  • Have taken, within 14 days of planned dosing, any prescription or non-prescription medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs) unless the Principal Investigator/Sub-Investigator, in consultation with the Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescription drugs will be grounds for exclusion).
  • Have donated a unit of blood within the preceding 4-week period.
  • Have allergy to either sulfa- or penicillin-based drugs.
  • Have a history of vagal responses resulting in bradycardia.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    AB103 7.5 µg/kg

    AB103 7.5 µg/kg administered as a single IV infusion

    Drug: AB103

  • Experimental
    AB103 37.5 µg/kg

    AB103 37.5 µg/kg administered as a single IV infusion

    Drug: AB103

  • Experimental
    AB103 150 µg/kg

    AB103 150 µg/kg administered as a single IV infusion

    Drug: AB103

  • Experimental
    AB103 450 µg/kg

    AB103 450 µg/kg administered as a single IV infusion

    Drug: AB103

  • Placebo comparator
    Placebo

    Normal saline (0.9% sodium chloride) administered as a single IV infusion

    Drug: Placebo

Interventions

  • DrugAB103

    Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes

  • DrugPlacebo

    Single intravenous infusion of normal saline (0.9% sodium chloride) administered over approximately 10 minutes

06

What researchers measure

Primary outcomes

  1. Number Adverse Events (AEs)

    An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.

    Time frame: 2 weeks

  2. Number of Serious Adverse Events (SAEs)

    A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.

    Time frame: 2 weeks

  3. Number of Dose-limiting Toxicities (DLTs)

    DLTs were defined as the emergence of one or more selected AEs that reached a threshold that may justify stopping the trial.

    Time frame: 2 weeks

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve (AUC)

    Area under the plasma concentration-time curve (AUC) from time zero to infinity following a single dose of study drug, obtained via noncompartmental methods. It is an integrated measure of study drug plasma exposure.

    Time frame: Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

  2. Cmax

    Maximum plasma concentration

    Time frame: Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

  3. Apparent Terminal Plasma Half-life (T1/2)

    Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.

    Time frame: Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

  4. Clearance (CL)

    Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.

    Time frame: Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

07

Results

Posted Apr 27, 2021

Participant flow

Subjects were recruited at the University of Maryland School of Medicine starting 7 September 2010. The study concluded 10 April 2011.

Participant flow — Overall Study
MilestoneAB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlacebo
Started55555
Completed55555
Not completed00000

Outcome measures

PrimaryNumber Adverse Events (AEs)

An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.

Time frame:
2 weeks
Reported as:
Number · adverse events
Number Adverse Events (AEs)
adverse eventsAB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlacebo
Number Adverse Events (AEs)72193
PrimaryNumber of Serious Adverse Events (SAEs)

A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.

Time frame:
2 weeks
Reported as:
Number · serious adverse events
Number of Serious Adverse Events (SAEs)
serious adverse eventsAB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlacebo
Number of Serious Adverse Events (SAEs)00000
PrimaryNumber of Dose-limiting Toxicities (DLTs)

DLTs were defined as the emergence of one or more selected AEs that reached a threshold that may justify stopping the trial.

Time frame:
2 weeks
Reported as:
Number · DLTs
Number of Dose-limiting Toxicities (DLTs)
DLTsAB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlacebo
Number of Dose-limiting Toxicities (DLTs)00000
SecondaryArea Under the Plasma Concentration-time Curve (AUC)

Area under the plasma concentration-time curve (AUC) from time zero to infinity following a single dose of study drug, obtained via noncompartmental methods. It is an integrated measure of study drug plasma exposure.

Time frame:
Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.
Reported as:
Median · ng*min/mL
Area Under the Plasma Concentration-time Curve (AUC)
ng*min/mLAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kg
Area Under the Plasma Concentration-time Curve (AUC)527 (238 to 911)2085 (1740 to 2743)5831 (4214 to 9441)
SecondaryCmax

Maximum plasma concentration

Time frame:
Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.
Reported as:
Median · ng/mL
Cmax
ng/mLAB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kg
Cmax10.63 (7.35 to 11.97)52.67 (19.99 to 104.35)190.90 (160.77 to 295.21)611.19 (455.36 to 1031.71)
SecondaryApparent Terminal Plasma Half-life (T1/2)

Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.

Time frame:
Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.
Reported as:
Median · hours (h)
Apparent Terminal Plasma Half-life (T1/2)
hours (h)AB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kg
Apparent Terminal Plasma Half-life (T1/2)1.42 (0.78 to 1.83)1.36 (0.77 to 1.48)1.28 (1.16 to 1.67)
SecondaryClearance (CL)

Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.

Time frame:
Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.
Reported as:
Median · mL/min/kg
Clearance (CL)
mL/min/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kg
Clearance (CL)71 (41 to 158)72 (55 to 86)77 (48 to 107)

Adverse events

Collected over 2 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AB103 7.5 µg/kg0/5 (0%)0/5 (0%)1/5 (20%)
AB103 37.5 µg/kg0/5 (0%)0/5 (0%)1/5 (20%)
AB103 150 µg/kg0/5 (0%)0/5 (0%)1/5 (20%)
AB103 450 µg/kg0/5 (0%)0/5 (0%)2/5 (40%)
Placebo0/5 (0%)0/5 (0%)2/5 (40%)
Most frequent other events
Showing 10 of 15
Most frequent other events
EventAB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlacebo
Lacrimation increasedEye disorders1/50/50/50/50/5
Abdominal painGastrointestinal disorders1/50/50/50/50/5
FlatulenceGastrointestinal disorders1/50/50/50/50/5
FatigueGeneral disorders1/50/50/51/50/5
HeadacheNervous system disorders1/50/50/50/50/5
Nasal congestionRespiratory, thoracic and mediastinal disorders1/50/50/50/51/5
SneezingRespiratory, thoracic and mediastinal disorders1/50/50/50/50/5
Rash papularSkin and subcutaneous tissue disorders0/51/50/50/50/5
PruritisSkin and subcutaneous tissue disorders0/51/50/50/50/5
MyalgiaMusculoskeletal and connective tissue disorders0/50/51/51/50/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)AB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlaceboTotal
<=18 years000000
Between 18 and 65 years5555525
>=65 years000000
Age, Continuous
Age, Continuous(years)AB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlaceboTotal
Mean28 ± 729 ± 634 ± 530 ± 430 ± 830 ± 6
Sex: Female, Male
Sex: Female, Male(Participants)AB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlaceboTotal
Female211318
Male3442417
Region of Enrollment
Region of Enrollment(participants)AB103 7.5 µg/kgAB103 37.5 µg/kgAB103 150 µg/kgAB103 450 µg/kgPlaceboTotal
United States5555525
08

Study locations

1 site
  • University of Maryland School of Medicine
    Baltimore, Maryland 21201, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01166984
Lead sponsor
Atox Bio Ltd
Responsible party
Sponsor
First posted
Jul 21, 2010
Start date
Sep 2010
Primary completion
Jun 2011
Completion
Jun 2011
Results posted
Apr 27, 2021
Last update
Jun 9, 2021

Study contacts

Alan Cross, MD
principal investigator · University of Maryland, College Park

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: AB103

Other studies in this condition

Sepsis →

Other studies from this sponsor

Atox Bio Ltd

Start the discussion