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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
Awards & highlights
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 113 for sad part and d1 to day 169 for mad part
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 113 for sad part and d1 to day 169 for mad part
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Assessment of immunogenicity
Assessment of pharmacokinetic(PK) parameter AUClast in serum
Assessment of pharmacokinetic(PK) parameter AUCtau in serum (MAD only)
+1 moreOther outcome measures
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh at least 50 kg and my BMI is between 19 and 30.I often have headaches, migraines, or I vomit more than twice a month.I have a history of heart problems, including high blood pressure or irregular heartbeat.I have not had any psychiatric disorders, suicidal thoughts in the last 6 months, or any suicide attempts.I have had cancer other than skin cancer in the last 5 years.I am a healthy adult between 18 and 55 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: ABL301
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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