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

Healthy Volunteers Clinical Trial

Official title:

A 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723692
• Other study ID #: ALTB-268-101
• Status: Completed
• Phase: Phase 1
• Start date: January 17, 2023
• Est. completion date: October 27, 2023

Study information

• Verified date: February 2024
• Source: AltruBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• ALTB-268
monoclonal antibody

Other:
• Placebo
formulation buffer

Locations

Country	Name	City	State
United States	ICON Early Development Services	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
AltruBio Inc.	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacodynamics of ALTB-268 Receptor Occupancy	Receptor Occupancy will be measured using a flow cytometry based method	through study completion, up to day 120 of the study
Other	Exploratory Immunophenotyping Lymphocyte subsets	Lymphocyte subsets, T,B and NK cells will be assessed using a flow cytometry based method	through study completion, up to day 120 of the study
Other	Pharmacodynamics - change in target engagement biomarkers	inhibition of cytokine release from ex-vivo stimulated T cells and the change of soluble (free) PSGL-1 molecule	through study completion, up to day 120 of the study
Primary	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	Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.	Including AUC0-t, AUC0-inf, AUC0-tau	through study completion, up to day 120 of the study
Secondary	Pharmacokinetics of ALTB-268 Cmax	Maximum plasma concentration	through study completion, up to day 120 of the study
Secondary	Pharmacokinetics of ALTB-268 tmax	Time to reach Cmax	through study completion, up to day 120 of the study
Secondary	Pharmacokinetics of ALTB-268 t1/2	Half life	through study completion, up to day 120 of the study
Secondary	Pharmacokinetics of ALTB-268 CL/F	Apparent clearance, calculated as dose/AUC0-inf	through study completion, up to day 120 of the study
Secondary	Pharmacokinetics of ALTB-268 Rac	The ratio of accumulation of a drug after repeated administration as compared to a single dose, PART B only	through study completion, up to day 120 of the study