A Phase 1 interventional study of ALTB-268 and Placebo in Healthy Volunteers, sponsored by AltruBio Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by AltruBio Inc. · Phase 1, Interventional, and Treatment
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.
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.
AltruBio Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous dose in healthy volunteers
Biological: ALTB-268
Subcutaneous dose in healthy volunteers
Other: Placebo
monoclonal antibody
formulation buffer
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.
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.
Including AUC0-t, AUC0-inf, AUC0-tau
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Cmax
Maximum plasma concentration
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 tmax
Time to reach Cmax
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 t1/2
Half life
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 CL/F
Apparent clearance, calculated as dose/AUC0-inf
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Rac
The ratio of accumulation of a drug after repeated administration as compared to a single dose, PART B only
Time frame: through study completion, up to day 120 of the study
Pharmacodynamics of ALTB-268 Receptor Occupancy
Receptor Occupancy will be measured using a flow cytometry based method
Time frame: through study completion, up to day 120 of the study
Exploratory Immunophenotyping Lymphocyte subsets
Lymphocyte subsets, T,B and NK cells will be assessed using a flow cytometry based method
Time frame: through study completion, up to day 120 of the study
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
Time frame: through study completion, up to day 120 of the study
Ran from Jan 2023 to primary completion in Oct 2023, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ALTB-268
AltruBio Inc.