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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Placebo; Biological: ALTB-268

• Registration Number: NCT05723692
• Lead Sponsor: AltruBio Inc.

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.

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-13
• Primary Completion: 2023-10-27
• Study Completion: 2023-10-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subcutaneous dose in healthy volunteers
ALTB-268	ALTB-268	Subcutaneous dose in healthy volunteers

Primary Outcome Measures

Name	Time	Method
Incidence of ALTB-268 Treatment-Emergent Adverse Events	through study completion, up to day 120 of the study	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of ALTB-268 Cmax	through study completion, up to day 120 of the study	Maximum plasma concentration
Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.	through study completion, up to day 120 of the study	Including AUC0-t, AUC0-inf, AUC0-tau
Pharmacokinetics of ALTB-268 Rac	through study completion, up to day 120 of the study	The ratio of accumulation of a drug after repeated administration as compared to a single dose, PART B only
Pharmacokinetics of ALTB-268 t1/2	through study completion, up to day 120 of the study	Half life
Pharmacokinetics of ALTB-268 CL/F	through study completion, up to day 120 of the study	Apparent clearance, calculated as dose/AUC0-inf
Pharmacokinetics of ALTB-268 tmax	through study completion, up to day 120 of the study	Time to reach Cmax

Trial Locations

Locations (1)

ICON Early Development Services; 🇺🇸 Lenexa, Kansas, United States