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NCT04508179 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects
A Phase 1 study, sponsored by 7 Hills Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT04508179: Completed Phase 1 study, sponsored by 7 Hills Pharma.
NCT04508179 is a Phase 1 study that has completed, run by 7 Hills Pharma. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04508179, a Phase 1 study, has completed, sponsored by 7 Hills Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
Primary Outcome
Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests
Interventions
- DRUG 7HP349 Single Ascending Dose
- DRUG 7HP349 Multiple Ascending Dose
- DRUG Placebo Single Ascending Dose
- DRUG Placebo Multiple Ascending Dose
- DRUG 7HP349 Food Effect
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2021-10-25 |
| Phase | Phase 1 |
What the finished NCT04508179 record still lists
NCT04508179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which 7HP349 Single Ascending Dose is the first listed.
NCT04508179 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04508179 about?
NCT04508179 is a clinical study titled "A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects". This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
What is the current status of trial NCT04508179?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2020-10-28. Estimated completion is 2021-10-25.
What interventions are being tested in trial NCT04508179?
The interventions under investigation include: 7HP349 Single Ascending Dose (DRUG), 7HP349 Multiple Ascending Dose (DRUG), Placebo Single Ascending Dose (DRUG), Placebo Multiple Ascending Dose (DRUG), 7HP349 Food Effect (DRUG).
Who is sponsoring clinical trial NCT04508179?
This trial is sponsored by 7 Hills Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04508179's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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