Healthy ParticipantsPhase 1NCT05156034
A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SRK-001 in Healthy Participants
A Phase 1 study testing SRK-001 in people with Healthy Participants, run by Sarkana Pharma Inc at 1 site in Netherlands.
Trial summary
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of SRK-001 in Healthy Participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SRK-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Dec 2021to 5 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
- Must agree not to donate sperm from start of dosing until 90 days beyond the last dose of study intervention
- No restrictions are required for a vasectomized male
Show all 13Show fewer
- 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:
- hormonal contraceptives (oral, transdermal patches, vaginal, or injectable)
- intrauterine device with or without hormones
- condom, diaphragm, or cervical cap ('barrier' method)
- sexual abstinence, and
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of SRK-001 in Healthy Participants.
- Conditions
- Healthy Participants
- Being tested
- SRK-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRK-001Drug
Participants will receive IV doses of SRK-001.
PlaceboDrug
Participants will receive IV doses of placebo.
| Study group | Role | What they receive |
|---|---|---|
| SRK-001- Dose 1 | Experimental | Participants will receive intravenous (IV) SRK-001 every 2 weeks (Q2W) for 4 doses. Receives: Drug: SRK-001 |
| SRK-001- Dose 2 | Experimental | Participants will receive IV SRK-001 every 4 weeks (Q4W) for 2 doses. Receives: Drug: SRK-001 |
| SRK-001- Dose 3 | Experimental | Participants will receive IV SRK-001 Q2W for 4 doses. Receives: Drug: SRK-001 |
| Placebo | Placebo comparator | Participants will receive IV placebo Q2W for 4 doses or Q4W for 2 doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through final follow-up at approximately Day 155
Secondary outcomes (4)
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUC0-tau) at Steady State
Pharmacokinetics (PK) after single and multiple IV dosing.
Measured: Day 1 (End of the infusion [EOI]) up to Day 155 post EOI
Half-Life (t1/2)
PK after single and multiple IV dosing.
Measured: Day 1 (EOI) up to Day 155 post EOI
Concentrations at End of Infusion (Cmax)
PK after single and multiple IV dosing.
Measured: Day 1 (EOI) up to Day 155 post EOI
Concentrations at End of Dosing Interval (Ctrough)
PK after single and multiple IV dosing.
Measured: Day 1 (EOI) up to Day 155 post EOI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start21 Dec 2021
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Why it stopped: Due to occurrence of eye related adverse events.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarkana Pharma Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Sarkana Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156034
- Sponsor's protocol ID
- SRKMD-2021
- Other IDs
- 2021-003991-15
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05156034
- Acronym / sponsor ID
- SRKMD-2021
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to occurrence of eye related adverse events.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sarkana Pharma IncUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of SRK-001 in Healthy Participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SRK-001- Dose 1 | Experimental | Drug: SRK-001Participants will receive intravenous (IV) SRK-001 every 2 weeks (Q2W) for 4 doses. |
| SRK-001- Dose 2 | Experimental | Drug: SRK-001Participants will receive IV SRK-001 every 4 weeks (Q4W) for 2 doses. |
| SRK-001- Dose 3 | Experimental | Drug: SRK-001Participants will receive IV SRK-001 Q2W for 4 doses. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive IV placebo Q2W for 4 doses or Q4W for 2 doses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- 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:
- Has been fully vaccinated for COVID-19 with the last dose of vaccine administered at least 3 weeks prior to study intervention administration
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRK-001Participants will receive IV doses of SRK-001. | Drug | SRK-001- Dose 1, SRK-001- Dose 2, SRK-001- Dose 3 |
| PlaceboParticipants will receive IV doses of placebo. | Drug | Placebo |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
Time frame: Baseline through final follow-up at approximately Day 155
Number of participants with one or more TEAEs and SAEs will be reported in the adverse events module.
4 secondary outcomes
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUC0-tau) at Steady State
Time frame: Day 1 (End of the infusion [EOI]) up to Day 155 post EOI
Half-Life (t1/2)
Time frame: Day 1 (EOI) up to Day 155 post EOI
Concentrations at End of Infusion (Cmax)
Time frame: Day 1 (EOI) up to Day 155 post EOI
Concentrations at End of Dosing Interval (Ctrough)
Time frame: Day 1 (EOI) up to Day 155 post EOI
Results and safety
The study was stopped early (reason given: Due to occurrence of eye related adverse events.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Sarkana Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRK-001 in people with Healthy Participants, run by Sarkana Pharma Inc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to occurrence of eye related adverse events.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) (time frame: Baseline through final follow-up at approximately Day 155). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.