CClinicalTrials.gg
TerminatedNCT05156034Updated Mar 13, 2023

A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SRK-001 in Healthy Participants

A Phase 1 interventional study of SRK-001 and Placebo in Healthy Participants, sponsored by Sarkana Pharma Inc. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-13.

Sponsored by Sarkana Pharma Inc · Phase 1, Interventional, and Treatment

Why this study was terminated
Due to occurrence of eye related adverse events.

From the registry’s dates

  • Primary completion was Sep 2022, 4 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of SRK-001 in Healthy Participants.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

This is the only study on the registry with Sarkana Pharma Inc as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants who have clinical chemistry laboratory values within the acceptable range for the population, as per the investigator judgment
  • Body mass index of 18 to 32 kilogram (kg)/ square meter (m\^2)
  • Healthy male participants

    1. Nonvasectomized male participants must agree to abstain from sexual intercourse or use a condom as well as 1 additional highly effective method of contraception (less than [\<]1 percent [%] failure rate) or effective method of contraception with all sexual partners of childbearing potential during the study and for 90 days following the last dose of study intervention
    2. Must agree not to donate sperm from start of dosing until 90 days beyond the last dose of study intervention
    3. No restrictions are required for a vasectomized male
  • Healthy female participants of childbearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from screening to 90 days after the last dose of the study intervention. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:

    1. hormonal contraceptives (oral, transdermal patches, vaginal, or injectable)
    2. intrauterine device with or without hormones
    3. condom, diaphragm, or cervical cap ('barrier' method)
    4. sexual abstinence, and
    5. vasectomized partner
  • Has been fully vaccinated for COVID-19 with the last dose of vaccine administered at least 3 weeks prior to study intervention administration

Exclusion criteria

Exclusion Criteria:

  • For at least 30 days prior to randomization, participants must have no symptoms and/or signs of confirmed or suspected infection (including COVID-19) and must have completed any appropriate anti-infective treatment
  • Have any concomitant systemic disorder, human immunodeficiency virus (HIV) infection, current infection with hepatitis B virus (HBV) (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA, hepatitis C virus (HCV) (that is, positive for HCV ribo nucleic acid[RNA]), symptomatic herpes zoster within 6 months prior to screening, an eye condition currently requiring treatment for trauma, contact allergy, postsurgical, or conjunctivitis that may interfere with eye evaluations, active or latent tuberculosis (TB)
  • Are currently enrolled in or have participated in greater than (>) 4 clinical trials in the past 12 months involving a study intervention or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study or have received a. any nonbiologic IP within 30 days or 5 half-lives (whichever is longer) of their baseline (Day -1) visit, or b. any biologic IP within 3 months or 5 half-lives (whichever is longer) of their baseline (Day -1) visit
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females) or are unwilling to stop alcohol consumption from 48 hours prior to each dosing (1 unit = 12 ounce [oz] or 360 milliliter [mL] of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Drug abuse in the past 12 months and/or show positive findings on drug screening unless they were prescribed by a physician (for example, benzodiazepines)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    SRK-001- Dose 1

    Participants will receive intravenous (IV) SRK-001 every 2 weeks (Q2W) for 4 doses.

    Drug: SRK-001

  • Experimental
    SRK-001- Dose 2

    Participants will receive IV SRK-001 every 4 weeks (Q4W) for 2 doses.

    Drug: SRK-001

  • Experimental
    SRK-001- Dose 3

    Participants will receive IV SRK-001 Q2W for 4 doses.

    Drug: SRK-001

  • Placebo comparator
    Placebo

    Participants will receive IV placebo Q2W for 4 doses or Q4W for 2 doses.

    Drug: Placebo

Interventions

  • DrugSRK-001

    Participants will receive IV doses of SRK-001.

  • DrugPlacebo

    Participants will receive IV doses of placebo.

06

What researchers measure

Primary outcomes

  1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)

    Number of participants with one or more TEAEs and SAEs will be reported in the adverse events module.

    Time frame: Baseline through final follow-up at approximately Day 155

Secondary outcomes

  1. Area Under the Concentration Versus Time Curve During a Dosing Interval (AUC0-tau) at Steady State

    Pharmacokinetics (PK) after single and multiple IV dosing.

    Time frame: Day 1 (End of the infusion [EOI]) up to Day 155 post EOI

  2. Half-Life (t1/2)

    PK after single and multiple IV dosing.

    Time frame: Day 1 (EOI) up to Day 155 post EOI

  3. Concentrations at End of Infusion (Cmax)

    PK after single and multiple IV dosing.

    Time frame: Day 1 (EOI) up to Day 155 post EOI

  4. Concentrations at End of Dosing Interval (Ctrough)

    PK after single and multiple IV dosing.

    Time frame: Day 1 (EOI) up to Day 155 post EOI

07

Study locations

1 site
  • PRA Health Sciences
    Groningen, 9728 NZ, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05156034
Lead sponsor
Sarkana Pharma Inc
Responsible party
Sponsor
First posted
Dec 14, 2021
Start date
Dec 21, 2021
Primary completion
Sep 5, 2022
Completion
Sep 5, 2022
Last update
Mar 13, 2023

Study contacts

Study Director
study director · Sarkana Pharma Inc

Oversight

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

Not currently enrolling

This study is terminated, as verified in Mar 2023. 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.

Start the discussion