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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04508179

Enrollment

Registered

2020-08-11

Start date

2020-10-28

Completion date

2021-10-25

Last updated

2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Brief summary

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

Detailed description

This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts. Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349. Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.

Interventions

DRUG7HP349 Single Ascending Dose

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

DRUG7HP349 Multiple Ascending Dose

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

DRUGPlacebo Single Ascending Dose

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

DRUGPlacebo Multiple Ascending Dose

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

DRUG7HP349 Food Effect

Part C: 7HP349 Capsules, Food Effect

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

This study consists of three parts, Part A, Part B and Part C, which will be undertaken sequentially. Part A is a SAD study to determine the safety, tolerability and PK of 7HP349 in healthy male subjects, and to define the OPD. Part B is a MAD study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C is a crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria	17 days	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

Secondary

Measure	Time frame	Description
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by plasma exposure (AUClast and/or AUCinf) towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of plasma exposure (AUClast and/or AUCinf)
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of exposure in urine
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of renal clearance (CLr)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fed individuals	28 days	Fed prandial state, determination of maximum plasma concentration (Cmax)
Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD)	17 days	Determination of maximum plasma concentration (Cmax)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fasted individuals	28 days	Fasted prandial state, determination of maximum plasma concentration (Cmax)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fasted individuals	28 days	Fasted prandial state, determination of plasma exposure (AUClast and/or AUCinf)
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the maximum plasma concentration (Cmax) in fed vs. fasted individuals	28 days	Determination of Geometric Mean Ratio (GMR) of fed:fasted Cmax
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the plasma exposure (AUClast and/or AUCinf) in fed vs. fasted individuals	28 days	Determination of Geometric Mean Ratio (GMR) of fed:fasted AUClast and/or AUCinf
Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fed individuals	28 days	Fed prandial state, determination of plasma exposure (AUClast and/or AUCinf)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026