Phase 1 First‑in‑Human Study of the Phenylalanine‑Binding Polymer Phelimin in Healthy Volunteers and Adults With Classical Phenylketonuria

According to the sponsor, the number of enrolled subjects was not disclosed. The trial population comprised male individuals, encompassing both healthy volunteers and patients diagnosed with Phenylketonuria. The age range was indicated by a code (“3”) without further specification, and therefore the exact age limits are not available. Participants were selected to represent the two defined groups, but detailed selection criteria, including lifestyle factors such as diet, physical activity, or other habits, were not provided. Consequently, specific inclusion or exclusion criteria beyond gender and disease status were not described.

The study is a phase 1, first‑in‑human, randomized, double‑blind, controlled trial evaluating a phenylalanine‑binding polymer (phelimin) in healthy volunteers and adults with Phenylketonuria. Recruitment is scheduled to start on 1 June 2026 and end on 1 June 2027. Each participant will undergo a screening visit to confirm eligibility, a baseline visit for drug administration, scheduled follow‑up visits to assess safety, pharmacokinetics and tolerability, and a final end‑of‑study visit. Participant involvement extends from the screening through the end‑of‑study assessment, encompassing the entire study period. Early termination may occur if serious safety concerns arise, if the participant withdraws consent, or if protocol compliance cannot be maintained.