Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

A

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

  • Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
  • 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.
  • Ability to provide written informed consent and complying with all study requirements and restrictions.
  • Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening

Exclusion criteria

  • 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
  • Previous treatment with any GH Releasing Hormone (GHRH) analog.
  • Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
  • History of cancer within the past five years (excluding non-melanoma skin cancer).
  • History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
  • Subjects with a body weight > 120 kg.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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