Clinical trial · Interventional
A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects
A Phase 1, Placebo-controlled, Within-Cohort Randomized, Double-blind, Single and Multiple Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of 7HP349 in Normal Healthy Male Subjects
NCT04508179CI-TRIAL-00054823completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 7HP349 Food Effect | Drug | — | UNRESOLVED |
| 7HP349 Multiple Ascending Dose | Drug | — | UNRESOLVED |
| 7HP349 Single Ascending Dose | Drug | — | UNRESOLVED |
| Placebo Multiple Ascending Dose | Drug | — | UNRESOLVED |
| Placebo Single Ascending Dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 7HP349 Capsules
- description
- Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over)
- interventionNames
- Drug: 7HP349 Single Ascending Dose
- Drug: 7HP349 Multiple Ascending Dose
- Drug: 7HP349 Food Effect
- type
- PLACEBO_COMPARATOR
- label
- Placebo Capsules
- description
- Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts)
- interventionNames
- Drug: Placebo Single Ascending Dose
- Drug: Placebo Multiple Ascending Dose
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy males between the ages of 18 and 45 years, inclusive * Normal clinical chemistry, hepatic function, hematology, thyroid function * Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg * Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation * Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0 Exclusion Criteria: * Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator * History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin * Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody * Current treatment or treatment within 30 days with another investigational medication
References
Publications (0)
Data not yet available
No reference posted for this study.