A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers

NCT ID: NCT05723692

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2023-10-27

Brief Summary

This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.

Detailed Description

This is a Phase I, first-in-human, randomized, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ALTB-268 in healthy volunteers. Up to 40 and 24 healthy volunteers will be recruited in single and multiple ascending doses, respectively.

The primary objective is to assess the safety and tolerability of subcutaneously (sc) administered ALTB-268 in healthy volunteers. The secondary objective is to assess the plasma pharmacokinetics of sc administered ALTB-268 in healthy volunteers. The exploratory objectives are to assess the pharmacodynamics and evaluate immunogenicity of sc administered ALTB-268 in healthy volunteers.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ALTB-268

Subcutaneous dose in healthy volunteers

Group Type: EXPERIMENTAL

ALTB-268

Intervention Type: BIOLOGICAL

monoclonal antibody

Placebo

Subcutaneous dose in healthy volunteers

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

formulation buffer

Interventions

ALTB-268

monoclonal antibody

Intervention Type: BIOLOGICAL

Placebo

formulation buffer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Written Informed Consent and willingness to comply with the study restrictions.

2. Sex: male or female volunteers.

3. Age: 18 to 55 years, inclusive, at screening.

4. Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening.

5. Weight: 50 kg to 110 kg, inclusive, at screening.

6. Healthy volunteers: Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis

Exclusion Criteria

1. Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.

2. Use of any investigational drug or device within 30 days or five half-lives whichever is longer, of the first dose of study drug.

3. Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the volunteers.

4. Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in emergency department.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ICON plc

INDUSTRY

Sponsor Role: collaborator

AltruBio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Dickerson, MD

Role: PRINCIPAL_INVESTIGATOR

ICON plc

Locations

ICON Early Development Services

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

ALTB-268-101

Identifier Type: -

Identifier Source: org_study_id