Clinical trials

Phase 1b

Phase 1b clinical trial with HER-096 in Parkinson’s disease is ongoing.

The primary objective is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease.

The Phase 1b clinical study has two parts:

  • In Part 1, up to 12 healthy volunteer subjects will be dosed with a single dose for assessment of pharmacokinetic properties of HER-096.
  • In Part 2, up to 28 patients with Parkinson’s disease will be dosed for 4 week, 2 doses per week with either HER-096 or placebo to study the safety and tolerability of repeated subcutaneous doses of HER-096. The aim is also to evaluate selected biomarkers and discover and identify novel biomarkers in the Parkinson’s patients. The recruitment of patients will start after completing the Part 1 of the study.

The Phase 1b trial will be conducted in Finland.

The trial is registered at ClinicalTrials.gov with an ID NCT06659562.

More information about participation into the study can be found on the website:

osallistulaaketutkimukseen.fi/parkinsonin-tauti-laaketutkimus-c880/

Phase 1a

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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