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Monoclonal Antibodies

ABL301 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by ABL Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 113 for sad part and d1 to day 169 for mad part

Summary

This trial tests a new medicine for safety and how it affects the body. It's done in a safe and controlled way.

Who is the study for?
Healthy adults aged 18-55, with a body weight of at least 50 kg and BMI between 19-30 kg/m2 can join this trial. They must be in good health based on medical history, lab tests, physical exams, vital signs, and ECG results. Participants should not have frequent headaches or migraines, any cancer within the last five years (except certain skin cancers), significant heart issues or allergies as determined by the investigator.
What is being tested?
The study is testing ABL301 against a placebo to evaluate its safety and how it's processed by the body (pharmacokinetics) and its effects on the body's response (pharmacodynamics). It's a first-in-human study where participants are randomly assigned to receive either ABL301 or placebo in single ascending doses (SAD) and multiple ascending doses (MAD).
What are the potential side effects?
Since this is an early-phase trial for ABL301 in healthy volunteers, specific side effects are being investigated but are not yet known. Common side effects from similar studies may include injection site reactions, headache, fatigue, nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 113 for sad part and d1 to day 169 for mad part
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 113 for sad part and d1 to day 169 for mad part for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Assessment of immunogenicity
Assessment of pharmacokinetic(PK) parameter AUClast in serum
Assessment of pharmacokinetic(PK) parameter AUCtau in serum (MAD only)
+1 more
Other study objectives
Total alpha-synuclein in plasma

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ABL301Experimental Treatment1 Intervention
The single doses of ABL301 will be administered via IV infusion
Group II: PlaceboPlacebo Group1 Intervention
The single doses of placebo will be administered via IV infusion.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ABL Bio, Inc.Lead Sponsor
5 Previous Clinical Trials
357 Total Patients Enrolled

Media Library

ABL301 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05756920 — Phase 1
Healthy Subjects Research Study Groups: Placebo, ABL301
Healthy Subjects Clinical Trial 2023: ABL301 Highlights & Side Effects. Trial Name: NCT05756920 — Phase 1
ABL301 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05756920 — Phase 1
~0 spots leftby Jan 2025
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