Clinical trials

Herantis announced positive results from its Phase 1a clinical trial in healthy subjects in October 2023.

Topline data overview:

  • Overall good safety and tolerability profile in young and older healthy subjects. As expected, there were mild local injection site adverse events both in the HER-096 and the placebo groups.
  • Plasma pharmacokinetic (PK) profile in humans is well aligned with preclinical data. Maximum plasma concentration reached at the highest dose level (300 mg) was approximately 10 000 ng/ml and the plasma half-life was approximately 2 hours in all dose groups in young subjects and 2.5 hours in older subjects. Elimination of HER-096 occurred mainly via renal excretion as predicted by preclinical studies.
  • HER-096 concentration in cerebrospinal fluid (CSF) reached 50 – 100 ng/ml within 4 – 12 hours after a 200 mg subcutaneous dose of HER-096. This is in the predicted pharmacologically active CSF concentration range and is aligned with the preclinical data.

About the HER-096 Phase 1a clinical trial:

The Phase 1a trial was a randomized, double-blinded, placebo-controlled, safety, tolerability, and pharmacokinetic trial of subcutaneous single ascending doses of HER-096.

  • In part 1 of the trial, a single subcutaneous dose of HER-096 or placebo was administered to young, healthy, male subjects (20-45 years of age) to assess safety, tolerability, and the pharmacokinetic profile of HER-096 (plasma, urine) in six ascending dose groups, 6 dosed with HER-096 and 2 dosed with placebo in each dose group.
  • In the part 2 of the trial, 12 older healthy subjects (50-75 years of age), both males and females, were administered with a single dose of HER-096 to assess safety, tolerability, and the pharmacokinetic profile of HER-096 including blood-brain barrier penetration (plasma, urine, CSF).

In total, the trial recruited 60 healthy volunteer subjects. The trial took place at a single site in Finland and was conducted by the contract research organization Clinical Research Services Turku – CRST Oy.

The trial is registered at ClinicalTrials.gov with an ID NCT05915247.

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