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A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects

NCT04508179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-11-02

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects

Conditions

Interventions

DRUG

7HP349 Single Ascending Dose

Part A: 7HP349 Capsules, Single Ascending Dose (SAD)

DRUG

7HP349 Multiple Ascending Dose

Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)

DRUG

Placebo Single Ascending Dose

Part A: Placebo Capsules, Single Ascending Dose (SAD)

DRUG

Placebo Multiple Ascending Dose

Part B: Placebo Capsules, Multiple Ascending Dose (MAD)

DRUG

7HP349 Food Effect

Part C: 7HP349 Capsules, Food Effect

Sponsors & Collaborators

  • Frontage Clinical Services, Inc.

    collaborator UNKNOWN

  • 7 Hills Pharma, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2021-10-25
Completion
2021-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508179 on ClinicalTrials.gov