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

7 Hills Pharma

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: 7HP349 Food Effect; Drug: Placebo Single Ascending Dose; Drug: 7HP349 Single Ascending Dose; Drug: Placebo Multiple Ascending Dose; Drug: 7HP349 Multiple Ascending Dose

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04508179

7HP-101a

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

7HP349 Capsules

Experimental group

Description:

Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over)

Treatment:

Drug: 7HP349 Multiple Ascending Dose

Drug: 7HP349 Single Ascending Dose

Drug: 7HP349 Food Effect

Placebo Capsules

Placebo Comparator group

Description:

Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts)

Treatment:

Drug: Placebo Multiple Ascending Dose

Drug: Placebo Single Ascending Dose