Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

Aileron Therapeutics

Status and phase: Completed; Phase 1

Conditions: Growth Hormone Deficiency

Treatments: Drug: Placebo 0.15mg/kg; Drug: Placebo 0.015 mg/kg; Drug: ALRN-5281 0.15 mg/kg; Drug: ALRN-5281 0.015 mg/kg; Drug: Placebo 0.05mg/kg; Drug: ALRN-5281 0.05 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775358

ALRN-100-01

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.

Enrollment: 33 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
2. Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations.
3. Ability to provide written informed consent and complying with all study requirements and restrictions.
4. Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening

Exclusion criteria

1. History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator
2. Previous treatment with any GH Releasing Hormone (GHRH) analog.
3. Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
4. History of cancer within the past five years (excluding non-melanoma skin cancer).
5. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
6. Subjects with a body weight > 120 kg.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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33 participants in 6 patient groups, including a placebo group

ALRN-5281 0.015 mg/kg

Experimental group

Description:

Dosage-0.015 mg/kg

Treatment:

Drug: ALRN-5281 0.015 mg/kg

ALRN-5281 0.05 mg/kg

Experimental group

Description:

Dosage- 0.05 mg/kg

Treatment:

Drug: ALRN-5281 0.05 mg/kg

ALRN-5281 0.15 mg/kg

Experimental group

Description:

Dosage- 0.15 mg/kg

Treatment:

Drug: ALRN-5281 0.15 mg/kg

Placebo 0.015 mg/kg

Placebo Comparator group

Description:

Dosage- 0.015 mg/kg

Treatment:

Drug: Placebo 0.015 mg/kg

Placebo 0.05 mg/kg

Placebo Comparator group

Description:

Dosage- 0.05 mg/kg

Treatment:

Drug: Placebo 0.05mg/kg

Placebo 0.15 mg/kg

Placebo Comparator group

Description:

Dosage - 0.15 mg/kg

Treatment:

Drug: Placebo 0.15mg/kg