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

NCT05723692 | Completed Phase 1 FDA Drug

• 1 other identifier: ALTB-268-101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of ALTB-268 Treatment-Emergent Adverse Events

  Adverse events (AEs) - severity of the AEs will be graded using the most current version of the Common Terminology Criteria for AE (CTCAE) (V5.0) 5-point scale. The relationship between AEs and the study drug will be indicated as related or not related.

  through study completion, up to day 120 of the study

Secondary Outcomes (6)

• Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.

  through study completion, up to day 120 of the study

• Pharmacokinetics of ALTB-268 Cmax

  through study completion, up to day 120 of the study

• Pharmacokinetics of ALTB-268 tmax

  through study completion, up to day 120 of the study

• Pharmacokinetics of ALTB-268 t1/2

  through study completion, up to day 120 of the study

• Pharmacokinetics of ALTB-268 CL/F

  through study completion, up to day 120 of the study

Other Outcomes (3)

• Pharmacodynamics of ALTB-268 Receptor Occupancy

  through study completion, up to day 120 of the study

• Exploratory Immunophenotyping Lymphocyte subsets

  through study completion, up to day 120 of the study

• Pharmacodynamics - change in target engagement biomarkers

  through study completion, up to day 120 of the study

Study Arms (2)

ALTB-268

EXPERIMENTAL

Subcutaneous dose in healthy volunteers

Biological: ALTB-268

Placebo

PLACEBO COMPARATOR

Subcutaneous dose in healthy volunteers

Other: Placebo

Interventions

ALTB-268 BIOLOGICAL

monoclonal antibody

ALTB-268

Placebo OTHER

formulation buffer

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written Informed Consent and willingness to comply with the study restrictions.
• Sex: male or female volunteers.
• Age: 18 to 55 years, inclusive, at screening.
• Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening.
• Weight: 50 kg to 110 kg, inclusive, at screening.
• 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

You may not qualify if:

• 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.
• Use of any investigational drug or device within 30 days or five half-lives whichever is longer, of the first dose of study drug.
• Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the volunteers.
• 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.

Sponsors & Collaborators

• AltruBio Inc.: lead
• ICON plc: collaborator

Study Sites (1)

ICON Early Development Services

Lenexa, Kansas, 66219, United States

Location

Study Officials

• Daniel Dickerson, MD

  ICON plc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study consists of 2 parts: Part A: a single ascending dose (SAD) and Part B: multiple ascending dose (MAD).

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 13, 2023
• Study Start: January 17, 2023
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

US (1)