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Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants
NCT07350577 · AltruBio Inc.
In plain English
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Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety Tolerability, Pharmacokinetics, and Pharmacosymics of Single Ascending Doses of Intravenously Administerted ALTB-268 in Healthy Participants
About this study
This is a Phase I, randomized, double-blind, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenously administered ALTB-268 in healthy participants. Approximately 24 healthy participants will be recruited.
The primary objective is to evalute the safety and tolerability of intravenous infusion of SAD in healthy participants. The secondary objectives are (1) to characterize the PK profile of ALTB-268 in plasma following single IV doses in healthy participants, and (2) to assess the PD of ALTB-268 following single IV doses in healthy participants.
Eligibility criteria
Inclusion Criteria:
1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body mass index (BMI) \>18.5 and \<32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
2. Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic diseases.
3. Female participants of non-childbearing potential must be:
1. post-menopausal (spontaneous amenorrhea for at least 12 consecutive months prior to dosing) with confirmation by documented follicle- stimulating hormone (FSH) levels ≥40 mIU/mL; or
2. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal ligation) at least 3 months prior to dosing.
4. Able to understand the study procedures, agree to comply with all study visits, procedures, and restrictions, agree to comply with the prescribed dosage regimens and communicate to study personnel about AEs and concomitant medication use, and provide signed informed consent to participate in the study.
Exclusion Criteria:
1. Any clinically significant abnormal finding at physical examination at screening and/or Day -1.
2. Clinically significant abnormal laboratory test results at screening and/or Day -1; or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.
3. Any history of suicidal ideation as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at screening, or any history of suicide attempts.
4. Any history of clinical depression.
5. C-SSRS score at Day -1 (baseline) above Type 1 ideation.
6. PHQ-8 total score ≥5 at screening and/or Day -1 (baseline).
Study design
Enrollment target: 24 participants
Allocation: randomized
Masking: double
Age groups: adult
Timeline
Starts: 2025-11-17
Estimated completion: 2026-07-28
Last updated: 2026-01-20
Interventions
Biological: ALTB-268Other: Placebo
Primary outcomes
- • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Adverse Events (Through study completion, up to day 71 of the study)
- • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - Infusion Site Assessments (Through study completion, up to day 71 of the study)
- • To evaluate the safety and tolerability of ALTB-268 following intravenous (IV) infusion in healthy participants - C-SSRS (Through study completion, up to day 71 of the study)
Sponsor
AltruBio Inc. · industry
Contacts & investigators
ContactSimona Reed, Ph.D. · contact · simona.reed@altrubio.com · 415-757-0870
All locations (1)
Syneos Health Clinical Research Services, LLCRecruiting
Miami, Florida, United States